RIFM fragrance ingredient safety assessment, Isopulegol, CAS Registry Number 89-79-2

A M Api; D Belsito; S Bhatia; M Bruze; P Calow; M L Dagli; W Dekant; A D Fryer; L Kromidas; S La Cava; J F Lalko; A Lapczynski; D C Liebler; T M Penning; V T Politano; G Ritacco; D Salvito; T W Schultz; J Shen; I G Sipes; B Wall; D K Wilcox

doi:10.1016/j.fct.2016.08.001

RIFM fragrance ingredient safety assessment, Isopulegol, CAS Registry Number 89-79-2

Food Chem Toxicol. 2016 Nov:97S:S129-S135. doi: 10.1016/j.fct.2016.08.001. Epub 2016 Aug 3.

Authors

A M Api¹, D Belsito², S Bhatia³, M Bruze⁴, P Calow⁵, M L Dagli⁶, W Dekant⁷, A D Fryer⁸, L Kromidas³, S La Cava³, J F Lalko³, A Lapczynski³, D C Liebler⁹, T M Penning¹⁰, V T Politano³, G Ritacco³, D Salvito³, T W Schultz¹¹, J Shen³, I G Sipes¹², B Wall³, D K Wilcox³

Affiliations

¹ Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ 07677, USA. Electronic address: [email protected].
² Member RIFM Expert Panel, Columbia University Medical Center, Department of Dermatology, 161 Fort Washington Ave., New York, NY 10032, USA.
³ Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ 07677, USA.
⁴ Member RIFM Expert Panel, Malmo University Hospital, Department of Occupational & Environmental Dermatology, Sodra Forstadsgatan 101, Entrance 47, Malmo, SE-20502, Sweden.
⁵ Member RIFM Expert Panel, Humphrey School of Public Affairs, University of Minnesota, 301 19th Avenue South, Minneapolis, MN 55455, USA.
⁶ Member RIFM Expert Panel, University of Sao Paulo, School of Veterinary Medicine and Animal Science, Department of Pathology, Av. Prof. dr. Orlando Marques de Paiva, 87, Sao Paulo CEP, 05508-900, Brazil.
⁷ Member RIFM Expert Panel, University of Wuerzburg, Department of Toxicology, Versbacher Str. 9, 97078, Würzburg, Germany.
⁸ Member RIFM Expert Panel, Oregon Health Science University, 3181 SW Sam Jackson Park Rd., Portland, OR 97239, USA.
⁹ Member RIFM Expert Panel, Vanderbilt University School of Medicine, Department of Biochemistry, Center in Molecular Toxicology, 638 Robinson Research Building, 2200 Pierce Avenue, Nashville, TN 37232-0146, USA.
¹⁰ Member of RIFM Expert Panel, University of Pennsylvania, Perelman School of Medicine, Center of Excellence in Environmental Toxicology, 1316 Biomedical Research Building (BRB) II/III, 421 Curie Boulevard, Philadelphia, PA 19104-3083, USA.
¹¹ Member RIFM Expert Panel, The University of Tennessee, College of Veterinary Medicine, Department of Comparative Medicine, 2407 River Dr., Knoxville, TN 37996-4500, USA.
¹² Member RIFM Expert Panel, Department of Pharmacology, University of Arizona, College of Medicine, 1501 North Campbell Avenue, P.O. Box 245050, Tucson, AZ 85724-5050, USA.

PMID: 27495825
DOI: 10.1016/j.fct.2016.08.001

Abstract

This material was evaluated for genotoxicity, repeated dose toxicity, developmental and reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, as well as environmental safety. Data show that this material is not genotoxic nor does it have skin sensitization potential. The repeated dose, developmental and reproductive, and local respiratory toxicity endpoints were completed using the TTC (Threshold of Toxicological Concern) for a Cramer Class I material (0.03, 0.03 mg/kg/day and 1.4 mg/day, respectively). The phototoxicity/photoallergenicity endpoint was completed based on suitable UV spectra. The environmental endpoint was completed as described in the RIFM Framework.

Keywords: Developmental and reproductive toxicity; Environmental safety; Genotoxicity; Local respiratory toxicity; Phototoxicity/photoallergenicity; Repeated dose; Skin sensitization.

Publication types

Review

MeSH terms

Animals
Consumer Product Safety
Cyclohexane Monoterpenes
DNA Damage / drug effects
Dose-Response Relationship, Drug
Drug Evaluation, Preclinical
Endpoint Determination
No-Observed-Adverse-Effect Level
Perfume / chemistry
Perfume / toxicity*
Rats
Risk Assessment
Terpenes / chemistry
Terpenes / toxicity*
Toxicity Tests / methods*

Substances

Cyclohexane Monoterpenes
Perfume
Terpenes
isopulegol